Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zimmer Biomet Universal Navigation System

K-Number: K192133 · 2019-10-29

ApplicantZimmer Biomet Spine, Inc.
Decision Date2019-10-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet Universal Navigation System is a medical device manufactured by Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2019-10-29 under approval number K192133. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Biomet Universal Navigation System?

Zimmer Biomet Universal Navigation System is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Zimmer Biomet Spine, Inc.. The 510(k) number is K192133.

When was Zimmer Biomet Universal Navigation System approved by the FDA?

Zimmer Biomet Universal Navigation System received FDA 510(k) clearance on 2019-10-29, under approval number K192133.

What company makes Zimmer Biomet Universal Navigation System?

Zimmer Biomet Universal Navigation System is manufactured by Zimmer Biomet Spine, Inc..

What is the FDA product code for Zimmer Biomet Universal Navigation System?

The FDA product code for Zimmer Biomet Universal Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Zimmer Biomet Spine, Inc.

K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument System K171907Vitality® Spinal Fixation System K163543Biomet Fusion System K180227Polaris Spinal Growth System K171495Zyston Strut Open Titanium Spacer System K191722Vital Navigation System

View all 15 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑